We pay attention to the details.
We exceed expectations.

MedTech Review delivers results

Our team covers a wide range of services to meet your medical device submission, regulatory compliance, and quality management system needs. We specialize in helping our clients save both time and money. 

We are seasoned professionals

building effective compliance programs and submissions

for medical device manufacturers.

We believe a medical device is only valuable when it's available.  And like you, we feel the urgency to place safe and effective medical devices in markets around the world and keep them there.​

Global Medical Device Consultants
Submissions and Compliance
Results Oriented 

Contact us

We’re here when you need us.
  • Quality Management Systems
  • Audits: GMP (21 CFR 820), ISO 13485:2016, MDSAP audits, Mock FDA, GAP Analysis, Quality Planning (ISO 10005)
  • Corrective and Preventive Actions; Managing FDA 483s, Untitled Letters, Warning Letters
  • Global Product Registrations (e.g., 510k/De Novo eSTAR, Health Canada)
  • electronic MDR Agent (21 CFR 803)
  • US Agent
  • Certifications - MDSAP, ISO 13485​